From time to time, I field questions centered around FDA press releases and what they say. Every time I would have to go hunt and peck through years of releases to get an answer. Eventually I just put them into a data base so that I could track them categorically and end the scavenger hunt. In February of this year after completing it, I posted a review of the previous year’s releases and what they said and there was a good deal of interest in it – so here is an update looking at the first six months of 2014 – which I can scarcely believe are already over.
What does the agency that oversees the regulation of one-quarter of the U.S. economy have to say for itself? Here is an overview by subject matter:
To put that in context, the chart below compares the first six months of 2013 with the first six months of 2014. A few bullet points of observations:
- There were slightly fewer releases in the first half of 2014 compared to last year;
- There was a significant drop in the numbers of releases related to drugs and an increase in those referring to devices;
- There were slightly fewer announcements regarding approvals – 44 in 2013 compared to 40 in 2014, but perhaps more interesting was the fact that last year nearly 80% of approval announcement involved drugs while this year that dropped to 63%. Correspondingly, last year by this time there were 8 device approvals announced – a number which has nearly doubled to 15 for this year.
- There have been slightly fewer public health alerts and far fewer recalls, but there has been a slight increase in the numbers of new rules and guidances that were announced.
Here it is strictly by the numbers: